Code of Federal Regulations · Section

§ 864.5700 — Automated Platelet Aggregation System

21 C.F.R. § 864.5700

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(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

(b) Classification. Class II (performance standards).

Authorizing Statute